US7628760B2 - Circulation monitoring system and method - Google Patents

Circulation monitoring system and method Download PDF

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US7628760B2
US7628760B2 US12/001,505 US150507A US7628760B2 US 7628760 B2 US7628760 B2 US 7628760B2 US 150507 A US150507 A US 150507A US 7628760 B2 US7628760 B2 US 7628760B2
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signal
transducer
circulation
processor
extremity
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US20090149764A1 (en
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Herbert J. Semler
Philip Benz
Gary Mills
James McNames
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Semler Scientific Inc
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Semler Scientific Inc
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Assigned to SEMLER SCIENTIFIC, INC. reassignment SEMLER SCIENTIFIC, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SEMLER, HERBERT J., MCNAMES, JAMES, MILLS, GARY, BENZ, PHILIP
Priority to PCT/US2008/013592 priority patent/WO2009075855A1/fr
Priority to EP08860645A priority patent/EP2265170A1/fr
Publication of US20090149764A1 publication Critical patent/US20090149764A1/en
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Publication of US7628760B2 publication Critical patent/US7628760B2/en
Priority to US13/374,324 priority patent/US20130261468A1/en
Priority to US14/824,774 priority patent/US20150342468A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02416—Detecting, measuring or recording pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14552—Details of sensors specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6825—Hand
    • A61B5/6826—Finger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6829—Foot or ankle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6838—Clamps or clips

Definitions

  • the invention relates generally to the field of medical monitoring. More particularly, the invention relates to circulation monitoring and indexing to indicate the merit of a subject's circulation.
  • PDA Peripheral artery disease
  • CHD coronary heart disease
  • CVD cardiovascular disease
  • PAD puts patients at elevated risk for lower extremity atherosclerosis, as well as for CHD or CVD, heart attack, stroke, and amputation. Approximately 75% of patients having PAD also have CHD or CVD. Risk of stroke is three times higher in patients with PAD than in those without the condition. PAD manifests as stenosis or obstruction of the arteries in the lower extremities and is caused by several factors including atherosclerosis, thrombosis, arterial calcification, diabetes, homocysteinemia, etc.
  • PAD ulcerative colitis
  • a common diagnostic pathway includes use of the Ankle-Brachial Index (ABI) either at rest or during exercise, reactive hyperemia, photoplethysmography, segmental blood pressure analysis, pulse volume recording, duplex ultrasound, and peripheral angiography.
  • ABSI Ankle-Brachial Index
  • the ABI is typically the first test deployed and is usually performed in a physician's office or hospital vascular laboratory.
  • the ABI is calculated from observations of systolic blood pressures taken from the brachial artery and at the ankle using sphygmomanometers and Doppler ultrasound.
  • NIBP non-invasive blood pressure
  • Conventional photoplethysmography devices measure the volume of blood in a region of a subject's tissue.
  • Conventional pulse oximeters measure how much oxygen binds to hemoglobin in red blood cells in a region of a subject's tissue. Neither concerns itself with a measure of quasi-periodic or cardio-rhythmic blood flow or circulation in a subject's extremity.
  • FIG. 1 is an isometric view of the invented device in accordance with one embodiment of the invention.
  • FIG. 2 is a schematic diagram of the invented device shown in FIG. 1 .
  • FIG. 3 is a process flow diagram illustrating the invented circulation monitoring method.
  • FIG. 4 is a graph of a typical circulation index derived from the invented circulation monitoring method.
  • Described herein are the design and mechanics of providing a “circulation index” for monitoring and indexing cardio rhythmic components in biomedical signals. Only those fluctuations in the monitored signal that are synchronous with the cardiac cycle such as arterial blood pressure, central venous pressure, and photo-plethysmograph are of interest. The index is derived from these fluctuations and is coded into a simple indicator easily read by a patient.
  • any periodic signal can be exactly represented as a sum of sinusoids, called a Fourier series, with frequencies at integer multiples of the fundamental frequency, in accordance with Equation 1:
  • PSD power spectral density
  • x ⁇ ( t ) ⁇ 0 ⁇ ⁇ a ⁇ ( f ) ⁇ cos ⁇ [ 2 ⁇ ⁇ ⁇ ft + ⁇ ⁇ ( f ) ] ⁇ d f , ( 2 ) wherein those of skill in the art will appreciate that a(f) 2 is the PSD.
  • Quasi-periodic signals have their power concentrated at frequencies near integer multiples of the fundamental frequency, much like a Fourier series.
  • a signal that is lacking quasi-periodic fluctuations will typically lack power at concentrated frequencies and will instead have the power more or less equally distributed across all frequencies.
  • Signals that contain only white noise, or uncorrelated sequences, have a PSD that is equal across all frequencies.
  • SFM spectral flatness measure
  • the arithmetic mean is never smaller than the geometric mean, so the SFM is on a normalized scale between 0 and 1. If strong quasi-periodic components are present, then the PSD will contain power concentrated primarily at a few frequencies and the SFM will be close to 0. If the signal only contains white noise, the PSD will be flat and the SFM will be close to 1. Although the SFM is normally defined over the entire frequency range of the PSD, it can also be applied to any band of frequencies.
  • the circulation index is a measure of how strong the quasi-periodic component of the signal, which is essentially the opposite of what the SFM estimates.
  • the PSD cannot be computed directly from a signal because it requires that the entire signal be observed. Instead the PSD must be estimated from a finite segment, typically with a sliding window approach. Those of skill in the art will appreciate that, within the spirit and scope of the invention, there are many methods to estimate the PSD, both parametric and nonparametric.
  • the analysis of the received light-dark fluctuation values reduces “noise”, i.e. optical signal unrelated to the cardiac cycle elements of this light-dark fluctuations and enhances discrimination of the signal arising from the cardiac cycle elements of the light-dark fluctuations in the monitored area of the subject's extremity.
  • the change in this signal i.e. the CI, varies with the degree of circulation.
  • CI is a dynamic measurement for each subject.
  • CI observations are more stable from one observation on a subject to the next.
  • the invention involves a new method and apparatus for the non-invasive assessment of peripheral artery disease (PAD) and/or related coronary heart disease (CHD) or cardiovascular disease (CVD) using a non-invasive circulation monitor and deriving from characteristics of light transmitted through a person's extremity, e.g. a finger or toe, a circulation index to visually annunciate whether and to what extent the person has PAD and/or CHD or CVD.
  • PID peripheral artery disease
  • CHD coronary heart disease
  • CVD cardiovascular disease
  • FIG. 1 is an isometric view of invented apparatus or system 10 in accordance with one embodiment of the invention.
  • apparatus 10 shows apparatus 10 as including a finger or toe “probe” or transducer 12 operatively coupled with a nearby processor 14 and a nearby indicator 16 .
  • probe 12 includes a photo emitter, e.g. an infrared (IR) light source 18 and a photo receptor, e.g. an IR light receptor 20 , the two cooperating to illuminate a region of a subject's extremity, e.g. a hand, foot, finger, thumb or toe, and to sense the transmitted or reflected light energy responsive to biomedical fluctuations in the extremity.
  • IR infrared
  • IR light receptor 20 the two cooperating to illuminate a region of a subject's extremity, e.g. a hand, foot, finger, thumb or toe, and to sense the transmitted or reflected light energy responsive to biomedical fluctuations in the extremity.
  • one such biomedical fluctuation represents cardio-
  • the light emitted by photo emitter 18 is characterized by a single wavelength of light.
  • a single wavelength of light may be used.
  • processor 14 and indicator 16 can be integrated into a housing that also encompasses probe 12 , or that such can be separately integrated into a remote housing 22 , as indicated.
  • Processor 14 and any attendant circuitry such as batteries, memory, and peripheral signal driving/receiving/conditioning circuitry will be described in more detail below by reference to FIG. 2 .
  • Indicator 16 will be understood in accordance with one embodiment of the invention to include one or more light emitting diodes (LEDs), e.g. three color-differentiated LEDs, that indicate to the subject or a clinician one condition chosen from a group consisting of normal, reduced and insignificant circulation in the extremity.
  • LEDs light emitting diodes
  • alternative display technologies e.g.
  • liquid crystal display LCD
  • organic light emitting diode OLED
  • micro-reflector etc. giving a graphical rendering of the windowed data or the circulation index derived therefrom
  • housing 22 can include other circuitry, e.g. buffered window data recording memory, and one or more external communication ports, e.g. a USB port for conveying recorded data to a nearby or remote location for oversight and archival purposes.
  • other circuitry e.g. buffered window data recording memory
  • external communication ports e.g. a USB port for conveying recorded data to a nearby or remote location for oversight and archival purposes.
  • illustrated probe 12 operates transitively, with photo emitter 18 and photo receptor 20 on opposite sides of the extremity, e.g. the finger or toe.
  • probe 12 can operate reflectively, with photo emitter 18 and photo receptor 20 on the same side of the extremity and with a reflective medium such as a mirror on the opposite side thereof or simply by reflection off the bone and tissue.
  • a reflective medium such as a mirror on the opposite side thereof or simply by reflection off the bone and tissue.
  • probe 12 can take alternative physical forms.
  • probe 12 can take the form of a flexible expanse not unlike an adhesive band aid that surrounds or substantially surrounds the finger or toe. (Such can be done in accordance with the teachings of the above-referenced body composition monitor patent application.) Or it can take the form of a rigid integrally formed band or ring that slips over or around and partially or completely encircles the end of the finger or toe, or a rigid integrally formed thimble-like cap that slips over the end of the finger or toe. Or it can take the form of a rigid formed and assembled spring clip that gently pinches the finger or toe.
  • probe 12 can take a suitable alternative form capable of illuminating and monitoring light/dark fluctuations in the subject's extremity, e.g. a hand or foot.
  • FIG. 2 is a schematic diagram of invented apparatus or system 10 shown in FIG. 1 .
  • FIG. 2 shows disposable probe or sensor 12 and control box or circuitry 24 in housing 22 interconnected via a flexible signal wiring harness or cable 26 .
  • Sensor 12 includes a battery 28 , an electronic chip 30 , infrared photo emitter 18 and infrared photo receptor 20 with a subject's finger or toe tissue T extending therebetween in a transmissive configuration.
  • Control circuitry 24 includes a battery 32 , a processor 34 , a USB port 36 , a graphic display or indicator 16 , and a connector 38 .
  • chip 30 transmits, receives and conditions signals to/from photo emitter 18 and photo receptor 20 , and is powered by battery 28 .
  • processor 34 commands and processes responsive signals to and from chip 30 , converts the signals to windowed cardio-rhythmic fluctuation data over a determined window of time, compares the level of such cardio-rhythmic data to defined threshold data, and drives graphic display or indicator 16 to indicate what is referred to herein as a circulation index, or coded indication of normal (good), reduced (bad) or insignificant (borderline) circulation.
  • a circulation index or coded indication of normal (good), reduced (bad) or insignificant (borderline) circulation.
  • an embodiment of a circulation monitoring apparatus comprises a transducer configured to illuminate and monitor light fluctuations through tissue within an anatomical extremity to produce a signal indicative of the fluctuations, the transducer including a photo emitter for emitting a light signal to illuminate the extremity and a photo receptor for receiving a light signal responsive thereto, a processor operatively coupled with the transducer, the processor configured to analyze the signal for periodicity and to measure the signal for amplitude, a comparator operatively coupled with the processor, the comparator configured to compare the measured amplitude of the signal to one or more predefined threshold amplitudes, and an indicator operatively coupled with the comparator, the indicator configured to indicate a circulation level from the comparator.
  • FIG. 3 is a process flow diagram illustrating the invented circulation monitoring method, and is best understood in light of the Data Processing Outline above.
  • FIG. 3 shows an LED (IR) control 40 , which drives a(n IR) sensor array 42 (referred to more simply herein as photo receptor 20 ), which drives an amplifier 44 , which drives an analog-to-digital (A-D) converter 46 , which drives a data buffer 48 that buffers sufficient data to feed the digital signal processing (DSP) software 50 executed by processor 34 (refer briefly back to FIG. 2 ).
  • IR LED
  • A-D analog-to-digital
  • DSP digital signal processing
  • Blackman windowing because of its selectivity and sharp roll-off or edges, step 56 ; a DFT-shifting step 58 ; a flatness calculation step 60 ; and a circulation index calculation step 62 are performed by executing instructions stored within a memory either within processor 34 or external thereto.
  • the circulation index is discriminated against or compared at 64 with stored categorical (contiguous interval) threshold levels, as described below, and a qualitative (e.g. good/bad/in-between) or quantitative (85%) measure of the subject's circulation is displayed at display 16 (refer briefly back to FIG. 2 .)
  • FIG. 4 is a graph of a typical circulation index derived from the invented circulation monitoring method.
  • the upper trace of FIG. 4 shows the transmitted or reflected light detected by the photo detector over a window of time, while the lower trace of FIG. 4 shows the derived circulation index over the same window of time (mapped into contiguous intervals and based upon power spectral density distributions of data from the transmitted light measurements).
  • FIG. 4 features a subject with good circulation, as the circulation index is consistently ⁇ 0.9 on a scale from 0.0 to 1.0. Subjects with PAD and/or CHD or CVD would have far lower circulation indices. As suggested by FIG.
  • transmitted light waveform and circulation index data can be recorded and optionally uploaded to a clinician for outplay, review, and/or archiving.
  • a clinician for outplay, review, and/or archiving.
  • Any suitable means such as wired or wireless conveyances including telephone, cable, Internet, and the like.
  • normal represented by a green light
  • reduced represented by a yellow light
  • insignificant represented by a red light
  • these thresholds can be set differently. It is believed that reduced or insignificant circulation indices indicate moderate to severe PAD.
  • the objective was to develop a simple, safe, accurate bedside monitor to detect circulation in patients with PAD (and possibly also CHD or CVD).
  • a custom optical probe that measures infrared light transmission through a finger or toe has been developed.
  • the invented hand-held device was fitted to the left and right second toe of twenty patients having PAD (mean age 72 years) and 20 age-matched healthy subjects (mean age 69 years).
  • the self-contained probe detected a degree of circulation in three levels which were indicated by color coded LED's. Green indicated good circulation; yellow indicated reduced or borderline circulation; and red indicated insignificant circulation.
  • the measurements were compared to the ankle brachial index (ABI) by an independent vascular specialist prior to the use of the test device. In other words, the gold-standard but difficult-to-use-and-interpret ABI was used to calibrate the invented apparatus and system.
  • the new lightweight, portable monitor for monitoring and indexing circulation is an accurate, objective means of distinguishing patients with PAD and normal age-matched subjects.
  • the portable, lightweight and optionally disposable probe is simply (requires no additional apparatus, e.g. auscultatory or other non-invasive blood pressure (NIBP), Doppler, cuffs, gels, etc.), quickly (deployment takes less than three minutes) fitted, and yet it can provide an integral or remote visual indicator of peripheral circulation. It has the potential to be a non-invasive screening test for PAD, suitable for outpatient or in-home assessment. Use of the invention is warranted and could improve patient self-monitoring and compliance, and demonstrably can delay progression of PAD by its early detection.
  • NIBP non-invasive blood pressure
  • PAD is a very important risk factor for identifying coronary artery disease and cerebrovascular disease, as they share common risk factors and pathogenesis.
  • a simple non-invasive test for peripheral vascular disease would identify PAD candidates, and would also serve as a beacon for potential co-existing coronary artery disease and cerebrovascular disease. Its recognition would allow early intervention with preventive measures such as diet, exercise, eliminating tobacco, medications and, if necessary, possible revascularization procedures for saving limbs and lives.

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Application Number Priority Date Filing Date Title
US12/001,505 US7628760B2 (en) 2007-02-28 2007-12-11 Circulation monitoring system and method
PCT/US2008/013592 WO2009075855A1 (fr) 2007-12-11 2008-12-10 Système et procédé de surveillance de circulation sanguine
EP08860645A EP2265170A1 (fr) 2007-12-11 2008-12-10 Système et procédé de surveillance de circulation sanguine
US13/374,324 US20130261468A1 (en) 2001-10-04 2011-12-20 Non-invasive portable dehydration diagnostic system, device and method
US14/824,774 US20150342468A1 (en) 2004-12-20 2015-08-12 Non-invasive valsalva maneuver (vm) heart failure diagnostic method and apparatus

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US90422107P 2007-02-28 2007-02-28
US12/001,505 US7628760B2 (en) 2007-02-28 2007-12-11 Circulation monitoring system and method

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US9636025B2 (en) 2012-08-15 2017-05-02 Nanyang Technological University Systems and methods for pedal revascularization assessment
US11206990B2 (en) 2013-01-23 2021-12-28 Pedra Technology Pte Ltd Deep tissue flowmetry using diffuse speckle contrast analysis
US20140316292A1 (en) * 2013-04-19 2014-10-23 Semler Scientific, Inc. Circulation Monitoring System
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DE102022100257B4 (de) 2022-01-06 2023-12-07 Biosign Medical Ug (Haftungsbegrenzt) Messaufnehmer zum Messen einer optisch messbaren, dynamischen Größe, insbesondere eines Pulses, sowie System und Verfahren zur Messung und Auswertung eines Pulses bzw. einer optisch messbaren, dynamischen Größe

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